Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis

Individuals with non-small-cell lung cancer (NSCLC) with metastases to the ipsilateral mediastinum or subcarinal lymph nodes (N2 disease) have poor long-term survival. This exploratory analysis from the randomized phase 3 CheckMate 77T study assessed clinical outcomes by nodal status in individuals with stage III NSCLC who received neoadjuvant nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab (nivolumab) versus neoadjuvant chemotherapy followed by surgery and adjuvant placebo (placebo). Here we show that among patients with N2 disease, nivolumab versus placebo improved event-free survival (1-year rate, 70% versus 45%; hazard ratio, 0.46 (95% confidence interval, 0.30-0.70)) and pathological complete response rate (22.0% versus 5.6%); 77% versus 73% had definitive surgery, of whom 84% versus 74% received a simple lobectomy. Furthermore, nivolumab improved outcomes versus placebo in patients with multistation N2 NSCLC (1-year event-free survival rate: 71% versus 46%; hazard ratio, 0.43 (0.21-0.88); pathological complete response rate, 29.0% versus 2.7%). In the N2 subgroup with definitive surgery, 67% and 59% of patients had nodal downstaging after surgery (57% versus 44% downstaged to node-negative disease). Median EFS in randomized patients with stage III non-N2 NSCLC was not reached with nivolumab and 17.0 months with placebo (1-year EFS rate, 74% versus 62%; hazard ratio, 0.60 (0.33-1.08)). No new safety signals were identified. These findings support perioperative nivolumab plus neoadjuvant chemotherapy as an efficacious treatment for stage III N2 disease and suggest that N2 status may not predict poor prognosis in resectable NSCLC treated with perioperative immunotherapy. ClinicalTrials.gov identifier: NCT04025879 .

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Journal
Nature Cancer
Published
2026-01-08
DOI
https://doi.org/10.1038/s43018-025-01104-z
Citations
1
Primary Topic
Lung Cancer Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
36.44

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article

Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis

Padma Sathyanarayana, Vipul Devas, Jonathan Spicer, Tina Cascone et al.
1 citations
Nature Cancer
Lung Cancer Diagnosis and Treatment
36.44
article

Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis

Padma Sathyanarayana, Vipul Devas, Jonathan Spicer, Tina Cascone, Fábio Franke, N. Frost, Mark M. Awad, Mariano Provencio, Cinthya Coronado Erdmann, Aurelia Alexandru, Yasutaka Watanabe, Fedor V. Moiseyenko, Florian Guisier, T. Jeroen Nicolaas Hiltermann, Shun Lu, Jie He, Phuong Tran, Fumihiro Tanaka, Annelies Janssens, Yang Gao
article en
1 citations

Abstract

Individuals with non-small-cell lung cancer (NSCLC) with metastases to the ipsilateral mediastinum or subcarinal lymph nodes (N2 disease) have poor long-term survival. This exploratory analysis from the randomized phase 3 CheckMate 77T study assessed clinical outcomes by nodal status in individuals with stage III NSCLC who received neoadjuvant nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab (nivolumab) versus neoadjuvant chemotherapy followed by surgery and adjuvant placebo (placebo). Here we show that among patients with N2 disease, nivolumab versus placebo improved event-free survival (1-year rate, 70% versus 45%; hazard ratio, 0.46 (95% confidence interval, 0.30-0.70)) and pathological complete response rate (22.0% versus 5.6%); 77% versus 73% had definitive surgery, of whom 84% versus 74% received a simple lobectomy. Furthermore, nivolumab improved outcomes versus placebo in patients with multistation N2 NSCLC (1-year event-free survival rate: 71% versus 46%; hazard ratio, 0.43 (0.21-0.88); pathological complete response rate, 29.0% versus 2.7%). In the N2 subgroup with definitive surgery, 67% and 59% of patients had nodal downstaging after surgery (57% versus 44% downstaged to node-negative disease). Median EFS in randomized patients with stage III non-N2 NSCLC was not reached with nivolumab and 17.0 months with placebo (1-year EFS rate, 74% versus 62%; hazard ratio, 0.60 (0.33-1.08)). No new safety signals were identified. These findings support perioperative nivolumab plus neoadjuvant chemotherapy as an efficacious treatment for stage III N2 disease and suggest that N2 status may not predict poor prognosis in resectable NSCLC treated with perioperative immunotherapy. ClinicalTrials.gov identifier: NCT04025879 .

Nature CancerVol. 7(1)
University Medical Center Groningen (NL), Memorial Sloan Kettering Cancer Center (US), The University of Texas MD Anderson Cancer Center (US), Central South University (CN), University of Groningen (NL), Shanghai Jiao Tong University (CN), University of Occupational and Environmental Health Japan (JP), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), McGill University Health Centre (CA), Shanghai Chest Hospital (CN), Humboldt-Universität zu Berlin (DE), Bristol-Myers Squibb (United States) (US), Antwerp University Hospital (BE), Hospital Universitario Puerta de Hierro Majadahonda (ES), Dana-Farber Cancer Institute (US), Institutul Oncologic Bucuresti (RO), Saitama Cancer Center (JP), State Budget Institution of Health St. Petersburg Clinical Research Center Specialized Types of Medical Care (RU), Xiangya Hospital Central South University (CN), Centro de Pesquisas Oncológicas (BR), Université de Rouen Normandie (FR)
Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Gilead Sciences, American Society of Clinical Oncology, F. Hoffmann-La Roche, Regeneron Pharmaceuticals, Taiho Pharmaceutical, Les Laboratories Pierre Fabre, Menarini Silicon Biosystems, BeiGene, Boehringer Ingelheim Japan, Apollomics, Yuhan, Moderna, European Commission, Eisai, Servier, Ono Pharmaceutical, Genentech, EMD Serono, Chugai Pharmaceutical, Takeda Oncology, Pfizer Canada, Eli Lilly Japan, Instituto de Salud Carlos III, Daiichi Sankyo Europe
No poverty
Openalex Percentile: Top 2%
Lung Cancer Diagnosis and Treatment
36.44
DOIOpen Access PDFOpenAlex
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